What is a clinical trial?

A clinical trial, also called a research study, is a biomedical or health-related research program involving people. It attempts to find new and improved methods of evaluating or treating a condition or finding a new way of preventing diseases. It follows a pre-defined protocol and tests the value and safety of certain treatments.

Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that do not allow someone to participate are called “exclusion criteria.”

What happens during a clinical trial?

For all types of trials, the participant works with a research team. The clinical trial team may include doctors, nurses, social workers and other healthcare professionals. The trial team checks the health of the participant at the beginning of the trial, gives specific instructions for participating in the trial, monitors the participant carefully during the trial and stays in touch after the trial is completed.

What is informed consent?

Informed consent is the process of explaining the details of the clinical trial to a patient before deciding whether or not to participate. The research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures and key contacts. Informed consent is not a contract and the participant may withdraw from the trial at any time.

What is a protocol?

A protocol is a study plan on which a clinical trial is based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.

What are the benefits of participating in a clinical trial?

Clinical trials allow eligible participants to play an active role in their own health care. They may help others by contributing to medical research, often obtaining access to new treatments before they are widely acceptable.

What are the risks of participating in a clinical trial?

The treatment may not be effective for the participant, or there may be unpleasant side effects. The study may require more time, including trips to the study site or additional treatments.

How is the safety of the participant protected?

The trial follows a controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals and to various government agencies. Individual participants’ names will remain secret and will not be mentioned in these reports.

What should people consider before participating in a trial?

People should know as much as possible about the clinical trial and feel comfortable asking the members of the healthcare team questions about it, the care expected while in a trial and the cost of the trial. Plan ahead and write down possible questions to ask the doctor, nurse or research coordinator. Bringing a friend or relative to an appointment can be valuable for support and information gathering.